ISO 15223-1 or ISO 980
The two standards, ISO 980 and ISO 15223-1, regulate the symbols that manufacturers are permitted to use for labeling medical devices.
In November 2017, the EU Commission harmonized ISO 15223-1 and added it to the list of harmonized standards. It thus replaces ISO 980 as the standard. The discussion of whether the EU had inadvertently removed ISO 980 from the list should now be over.
Read this article to find out what ISO 15223-1:2016 describes and requires and where you can obtain the symbols.
Update: The 2020 version is in the process of being approved (see below).
Regulatory background
The MDR obliges manufacturers to provide information on the labels (see Annex I, Section 23.2):
- The fact that the device is a medical device
- Contains human blood or plasma
- Contains medicinal products
- Has been sterilized
- Contains other substances such as biological materials of human or animal origin, carcinogenic, or toxic materials
- May or may not be reused
- etc.
Manufacturers usually use symbols to communicate this information clearly and using a minimum of space. These symbols, in turn, are defined by standards such as EN 980 and ISO 15223-1.
About ISO 15223-1
Structure of the standard
ISO 15223-1:2016 and its German equivalent, DIN EN ISO 15223, is a short standard with 48 pages.
- 10 pages of it are devoted to Annexes ZA to ZC, which establish the mapping between the requirements of the EU Medical Device Directives (MDD, AIMD, and IVD).
- The following 6 pages contain the foreword, introduction, definitions, and a few normative requirements, such as the size of the symbols derived from risk management. Here, ISO 15223-1 also requires the symbols to be used on the medical device, on the packaging and in the documentation provided (e.g., instructions for use).
- This is followed by 21 pages of tables presenting the symbols and their use.
- The rest of the document consists of blank pages, cover pages, and directories.
New version
The current harmonized version EN ISO 15223-1:2021 contains some new features and 25 new symbols.
The following changes have been made compared to DIN EN ISO 15223-1:2017-04
- Inclusion of 25 new symbols
- Update of the definitions taking into account DIN EN ISO 20417, DIN EN ISO 14971, and DIN EN ISO 13485
- Revision of the requirements for using symbols (4.2) (among other things, the first paragraph with a similar meaning has been completely reworded. In addition, the manufacturer “must” now specify the appropriate size of the symbol instead of just “shall”).
- Extension of the examples in informative Annex A to notes and examples for the use of symbols, including the joint use of several symbols
- Addition to the informative annexes on the relationship between this European Standard and the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices which is to be covered and the relationship between this European Standard and the general safety and performance requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices which is to be covered
- Change the title to “Symbols for use in the context of information to be provided by the manufacturer”
- Editorial revision
According to Annex I, Article 23.1 h) of the Medical Device Regulation MDR (2017/745), the corresponding new symbols must be used. Due to the harmonization of EN ISO 15223-1:2021, it is not always necessary to explain the symbols listed in the standard in the instructions for use. However, this only applies if it does not lead to higher risks from the device. Manufacturers should determine whether this is the case in usability studies.
However, if the device is intended for lay users, the symbols must always be explained. Manufacturers cannot assume that laypersons will understand symbols without an explanation. Time will tell whether the numerous new and very detailed symbols can be used in practice without a laser printer – especially when you consider that the implantation ID card, for which some symbols were probably specially created, is supposed to be the size of a credit card.
The additional symbols are as follows:
Example for the definition of symbols
ISO 15223-1:2016 determines the requirements for the presentation and use of symbols in tabular form. The tables contain the columns
- Symbol
- Symbol title
- Symbol description
- Requirements
- Informative notes
- Restriction of use
- Additional requirements
- Reg. no. ISO 7000
Using the “manufacturer” symbol as an example, this looks as follows:
| Symbol | Title | Description | Requirements | Informative notes | Restriction of use | Additional requirements | Reg. no. |
 | Manufacturer | Indicates the manufacturer of the medical device in accordance with EU Directives 90/385/EEC, 93/42/EEC, 98/97/EC | The symbol must appear together with the name and address of the manufacturer (i.e., the person placing the medical device on the market) close to the symbol. | Note 1: This symbol is used to indicate the information required in Europe. Note 2: The complete definitions […] | 3082 2011-10-02 |
DIN ISO 7000 is entitled “Graphic symbols on equipment.” The symbols defined therein are not limited to the area of medical devices.
The ISO website lists all symbols:
The ISO offers these for purchase. A free publication from MedTech Europe contains most of the symbols.
Change history
- 2022-08-17: Notes on the 2021 version added
- 2021-11-30: Publication from MedTech Europe added
- 2021-08-17: New version section updated
